A Phase 3, Multicenter, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Investigational Product in Patients With Systemic Lupus Erythematosus (SLE)

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    Recruiting
Updated on 8 November 2020

Summary

A Phase 3, Multicenter, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Investigational Product in Patients With Systemic Lupus Erythematosus (SLE)

Description

A Phase 3, Multicenter, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Investigational Product in Patients With Systemic Lupus Erythematosus (SLE)

Patient Inclusion Criteria:

  • Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria
  • Have positive antinuclear antibodies (ANA)
  • Agree not to become pregnant throughout the course of the trial
  • Have the appropriate Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)score at screening

Patient Exclusion Criteria

  • Have active severe Lupus kidney disease
  • Have active Central Nervous System or peripheral neurologic disease
  • Have received intravenous immunoglobulin (IVIg) within 180 days of randomization
  • Have active or recent infection within 30 days of screening
  • Have had a serious infection within 90 days of randomization
  • Have evidence or test positive for Hepatitis B
  • Have Hepatitis C
  • Are human immunodeficiency virus (HIV) positive
  • Have evidence of active or latent tuberculosis (TB)
  • Presence of significant laboratory abnormalities at screening
  • Have had a malignancy in the past 5 years, except for cervical carcinoma in-situ or basal cell or squamous epithelial skin cell that were completely resected with no reoccurrence in the 3 yrs prior to randomization
  • Have received greater than 40 mgs of prednisone or equivalent in the past 30 days
  • Have changed your dose of antimalarial drug in the past 30 days
  • Have changed your dose of immunosuppressive drug in the past 90 days
  • Have previously received rituximab

Details
Clinical Study IdentifierTX135255
Last Modified on8 November 2020

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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